OLDWICK, N.J., April 16, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the initiation of the rolling submission of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031), an anti-CD3 monoclonal antibody for the delay or prevention of clinical Type 1 Diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies.
Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis. Provention submitted the non-clinical module and expects to submit the clinical module in Q3 and the chemistry, manufacturing and controls (CMC) module in Q4 of 2020. Once the final module of the BLA has been submitted, FDA will make a filing decision and set a PDUFA goal date.
"The initiation of our BLA submission process represents an important milestone for Provention as we advance teplizumab toward the market as the first-ever treatment for patients at-risk of advancing to clinical type 1 diabetes," said Ashleigh Palmer, President & CEO of Provention Bio. "The data from the 'At Risk' Study, published last year, underscores the transformative therapeutic potential of teplizumab to delay or prevent the onset of clinical-stage, insulin-dependent, T1D. We remain on track to complete the BLA submission by year-end and look forward to working with the FDA as we advance the regulatory process."
In June 2019, data from the At-Risk trial, sponsored by the National Institutes of Health and conducted by TrialNet, was presented at the 79th Annual American Diabetes Association meeting and published in the New England Journal of Medicine. Results of this study demonstrated that a single 14-day course of teplizumab significantly delayed the onset of clinical-stage T1D, as compared to placebo, by a median of at least 2 years in at-risk children and adults.
Teplizumab has received both Breakthrough Therapy Designation from the FDA and PRIME designation from the European Medicines Administration, allowing for greater dialogue and increased likelihood of priority review and accelerated assessment by the two agencies, respectively.
About teplizumab (PRV-031):
Teplizumab (PRV-031), is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception, delay or prevention of type 1 diabetes (T1D). More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, PRV-031 has consistently demonstrated the capability of preserving beta cell function and reducing the need for exogenous insulin usage. PRV-031 has been granted Breakthrough Therapy designation from the U.S. Food and Drug Administration and PRIME designation by the European Medicines Administration. Provention is currently evaluating PRV-031 in patients with newly diagnosed clinical-stage T1D (the Phase 3 PROTECT Study).
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy focused on the prevention or interception of immune-mediated disease. Provention's mission is to source, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune diseases. Provention's diversified portfolio includes PRV-031 (teplizumab), a pre-commercial-stage candidate that has been shown to delay the onset of end-stage type one diabetes (T1D) in at-risk individuals with pre-symptomatic disease. The Company's portfolio includes additional clinical-stage product development candidates that have demonstrated proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.
Forward Looking Statements:
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to timing of submission of the BLA. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Provention's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial competition; our need for additional financing and the risks listed under "Risk factors" in our annual report on Form 10-K for the year ended December 31, 2019 and any subsequent filings with the Securities and Exchange Commission (SEC). As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.